Accuracy Evaluation for Software-based Visualization of GPi/GPe Anatomical Brain Structure Using Surgical Information Sciences Inc. Algorithms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Validation of the accurate visualization of brain structure based on SIS algorithms - 3
研究概览
简要总结
SIS has developed a software technology, based on machine learning and image processing, designed to enhance standard clinical images for the visualization of anatomical structures.
详细描述
A cohort of 34 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (7T) scanner. Images acquired on the 7T allow to visualize anatomical structures that are not easily identified on standard clinical images.
SIS software will be used to visualize selected anatomical features on the clinical image and the results will be compared with the images in the same subject obtained from the 7T MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below.
排除标准
- •MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g,. heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, artificial knee or hip, metal plates, pins, screws or wires anywhere in the body, any other metal implants, etc.
- •Pregnant women.
- •Subject under the age of 18.
结局指标
主要结局
Validation of the accurate visualization of brain structure based on SIS algorithms - 3
时间窗: Through study completion, up to 1 year
Difference in Dice Coefficient between measured brain structures
Validation of the accurate visualization of brain structure based on SIS algorithms - 2
时间窗: Through study completion, up to 1 year
Difference in distance between brain structure mean surface area
Validation of the accurate visualization of brain structure based on SIS algorithms - 1
时间窗: Through study completion, up to 1 year
Difference in distance between brain structure center of mass (COM)
次要结局
未报告次要终点